Making Functional movement for paralysis patients possible
Dr. Alan Hamlet, Founder and CEO of MYOLYN, discusses functional electrical stimulation, the importance of engaging a community such as SEMDA, and what it takes to navigate the medtech developmental pathway alongside value-added investors.
According to the Christopher and Dana Reeve Foundation there are 5.6 million Americans living with paralysis and 1.3 million suffering from the results of spinal cord injuries. Health and mobility have drastic impact on happiness and quality of life- and MYOLYN is a medical device company seeking to increase the quality of life for patients dealing with mobility problems. We were able to speak with Dr. Alan Hamlet, Founder and CEO of MYOLYN, following their win at SEMDA’s Orlando PitchRounds Road Show. Not only did he speak of the importance of engaging a community such as SEMDA, but also about the needs of medical device innovators for development pathway assistance and the importance of partnering with “value-added” investors.
Making functional movement for paralysis patients possible
MYOLYN exists to combine robotics with electrical stimulation in order to improve health and human performance. Behind this goal is the belief that robotics and functional electrical stimulation (FES) can be used to augment the human body in order to treat diseases, disorders and paralysis increasing the functionality of both able-bodied and less abled people. MYOLYN’s co-founders, Dr. Hamlet and CTO Dr. Matthew Bellman, both received their Ph.D.s in robotics from the University of Florida. The two teamed up to improve the lives of paralysis sufferers in a cost-effective way using robotics to create functional movements.
The company’s current portfolio of products includes the MyoCycle Pro and the MyoCycle Home. The former is a commercial physical therapy tool that therapists can use to help improve outcomes for their patients, while MyoCycle Home is designed from the ground up to be affordable and easy-to-use for home care. The team’s goal is that every person with spinal cord injury will have a MyoCycle in their home.
The MyoCycle uses FES to restore functionality to paralyzed muscle. By placing non-invasive electrode pads on the skin over target muscle groups and applying a small electrical current, the motor nerves are stimulated, causing the target muscles to contract. Precisely controlling the intensity and timing of the stimulation makes the muscles work together to produce a functional motion. MYOLYN uses machine-learning techniques to optimize the stimulation for each user, and principles from robotics to maximize safety and effectiveness.
“Humans are really just fleshy robots” claims Hamlet. “With the algorithms we created for use in the MyoCycle we are able to use robotics to optimize the intensity of the stimulation applied and where it is applied in order to maximize the work output.”
The team is helping develop the global electrical stimulation market, which was a $4.7 billion market in 2014 and is expected to increase to $7 billion by 2019. MYOLYN recently submitted their FDA 510k application on January 18, 2017.
Engaging the professionals and customers to increase likelihood of success
MYOLYN’s engagement with the Southeast’s medtech ecosystem has already begun to yield rewards. SEMDA Executive Director Jason Rupp invited and encouraged Hamlet to the Orlando roadshow to pitch MYOLYN. They won- and will pitch to the entire SEMDA ecosystem at the flagship conference in late April for a shot to win $10,000.
“The hardest part about bringing a medical device to market is doing everything needed to meet regulatory requirements,” says Hamlet. “We wanted to design with the regulatory pathway in mind: meeting FDA standards, keeping the price low for patients, hospitals and physical therapy practices while also designing for ease of use. That’s why we engaged a regulatory consultant early on. We sat down and spent time planning the entire design process before we even thought about designing.
“It is crucial to interact with customers at day one,” claims Hamlet. “You don’t have a company unless you have customers. A lot of people get excited about technology, but if you don’t have a customer willing to utilize your device, you really only have a technology, not a company.
“Worrying about our intellectual property (IP) kept me from talking to customers even earlier, but you get to the point where you have to talk to people to ensure that you build a good product. Don’t live in fear of someone stealing your IP because without early feedback you are really in the dark. Unearth the value of your idea by talking to customers. Figure out what they value about it and shape your product based off of those insights.”
Prioritizing investors that seek to add value- not just in the form of capital
“Myolyn brings a device that allows individuals suffering from paralysis, including spinal cord injuries, to use the big muscles,” says Jeff Fitzsimmons, Ph.D., professor of radiology at the University of Florida. “Improving circulation in the body’s extremities is a huge problem for people restricted to wheelchairs, and it also yields cardiovascular and mobility benefits.
“I was attracted not just to the idea, but Matt and Alan are perfect for this. They both possess valuable engineering backgrounds and high levels of enthusiasm around product development. What they are doing is not only worthwhile, but a huge advancement for a sizeable, underserved population, many of whom are veterans like myself, in the prime of their lives and passionate about exercise despite any physical limitations.”
“We look for ‘value-added’ investors who have been down a like development pathway from whom we can learn and optimally accelerate our journey from concept to commercialization,” Hamlet said. “Based on his experience with as a co-owner with medtech startup MRI Devices, Jeff is a perfect fit for us and we are grateful for his support.”
Intermagnetics General acquired MRI Devices in 2004.
While the MYOLYN team introduced their company with FES cycling, they envision a broader application of their technology. By utilizing robotics and automated FES in various therapeutic areas they will create a product portfolio that will improve performance for multiple disabilities and disorders.
Innovation: Concept to Commercialization at SEMDA 2017
Access the southeast’s regional medtech resources, concept to commercialization, at SEMDA 2017. Registration is now open!